BEUDAMED
    FDA Adverse Event Other Summary report: N

    HT50 VENTILATOR

    MDR report key: 1673414 · Received April 26, 2010

    Report

    Report Number
    3003135857-2010-00006
    Event Type
    Other
    Date Received
    April 26, 2010
    Date of Event
    March 25, 2010
    Report Date
    March 29, 2010
    Manufacturer
    FLIGHT MEDICAL
    Product Code
    CBK
    PMA / PMN Number
    K082724
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: THE REPORTED PROBLEM WITH ALL BUTTONS UNRESPONSIVE WAS DUPLICATED; HOWEVER, THE VENTILATOR SHUTDOWN WAS NOT CONFIRMED. A VISUAL INSPECTION OF THE RETURNED VENTILATOR DID NOT FIND ANYTHING UNUSUAL. WHEN THE RETURNED VENTILATOR WAS FIRST POWERED ON, IT DID NOT TURN ON BECAUSE THE BATTERY WAS COMPLETELY DEPLETED: NO UNIT SHUTDOWN WAS OBSERVED. THE BATTERY WAS CHARGED AND THE VENTILATOR WAS TURNED ON; HOWEVER, THE UNIT SHUTDOWN WAS STILL NOT DUPLICATED. WHEN THE VENTILATOR WAS CONNECTED TO AC POWER, IT IMMEDIATELY STARTED BEEPING. AIR WAY PRESSURE METER NEEDLE FLUCTUATED, THE DISPLAY BECAME BLANK AND ALL BUTTONS WERE UNRESPONSIVE. THE SUSPECTED CONTROL PANEL BOARD IN THE CUSTOMER'S VENTILATOR WAS REMOVED AND A KNOWN GOOD CONTROL PANEL BOARD WAS INSTALLED. RESULT: THE SAME PROBLEM OCCURRED. THE SUSPECTED MAIN BOARD IN THE CUSTOMER'S VENTILATOR WAS REMOVED AND A KNOWN GOOD MAIN BOARD WAS INSTALLED. RESULT: THE VENTILATOR FUNCTIONED NORMALLY AND THE BUTTONS WERE RESPONSIVE. THE VENTILATOR REGAINED A NORMAL FUNCTIONALITY AFTER MAIN BOARD AND CONTROL PANEL BOARD WERE REPLACED. THE FAULTY PARTS WILL BE FORWARDED TO THE MANUFACTURER FOR FURTHER ANALYSIS. CONTROL PANEL BOARD.

    Description of Event or Problem · 1

    REPORTEDLY, THE VENTILATOR SHUTDOWN DURING USE ON A PT. THE VENTILATOR KEPT ALARMING AFTER IT SHUTDOWN AND ALL BUTTONS WERE UNRESPONSIVE. THE VENTILATOR FINALLY RAN DOWN DUE TO THE DRAINED BATTERY POWER. THE VENTILATOR DID NOT GIVE A PROPER ALARM PRIOR TO SHUTDOWN. THE PT WAS MANUALLY VENTILATED AND THEN SWITCHED TO THE BACKUP VENTILATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HT50 VENTILATOR CBK FLIGHT MEDICAL HT50-H NA

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Required Intervention